Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction

Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction - Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025808

Enrollment

Registered

2017-01-23

Start date

2017-01-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Oral administration of 2.5 mg luseogliflozin once a day, pre or post breakfast for 52 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Aged >=20, =<80 at consent 2) Poorly glycemic controlled patients who undergo diet/exercise therapy or treatment with hypoglycemic agents for at least 12 weeks 3) HbA1c >= 6.5 and < 9.5% 4) BMI >= 20 kg/m2 5) Provide written informed consent 6) With hepatic dysfunction (ALT>=31 IU/L)

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes 2) Has history of severe ketosis, diabetic coma, or precoma 3) With severe infection, pre or post surgery, and serious trauma 4) With severe renal dysfunction (eGFR<30 mL/min/1.73m2) 5) Has stroke, myocardial infarction, or other serious cardiovascular complications requiring hospitalization within 6 months 6) Receiving SGLT2 inhibitor 7) Nursing or pregnant or planning to become pregnant 8) Has hypersensitivity to luseogliflozin or any other excipients of luseogliflozin 9) Considered as inadequate by the investigator

Design outcomes

Primary

Measure	Time frame
Change and percent change in AST, ALT, gamma-GTP, and HbA1c from baseline to 52 weeks	—

Secondary

Measure	Time frame
1) Change in the following items from baseline to 12 and 24 weeks - AST, ALT, gamma-GTP, HbA1c 2) Change in the following items from baseline to 12, 24, and 52 weeks - Fasting plasma glucose, HOMA-beta, HOMA-IR - Body weight, BMI, Waist circumference, and Blood pressure - NAFLD fibrosis score, FIB-4 index, FLI 3) Change in the following items from baseline to 24 and 52 weeks - Type IV collagen 7S domain, Ferritin, M2-BP, hs-CRP 4) Change in IL-6 from baseline to 52 weeks	—

Measure

Time frame

1) Change in the following items from baseline to 12 and 24 weeks - AST, ALT, gamma-GTP, HbA1c 2) Change in the following items from baseline to 12, 24, and 52 weeks - Fasting plasma glucose, HOMA-beta, HOMA-IR - Body weight, BMI, Waist circumference, and Blood pressure - NAFLD fibrosis score, FIB-4 index, FLI 3) Change in the following items from baseline to 24 and 52 weeks - Type IV collagen 7S domain, Ferritin, M2-BP, hs-CRP 4) Change in IL-6 from baseline to 52 weeks

—

Countries

Japan

Contacts

Public ContactHiroaki Seino

Seino Internal Medicine Clinic Medical director

kn7jh5@bma.biglobe.ne.jp024-983-1024

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026